Strengthen role for European Medicines Agency (EMA) welcomed – MEP Deirdre Clune
The EU is planning to be better equipped to manage future health crises. The European Parliament has approved a proposal to strengthen the European Medicines Agency (EMA), following on from the impact of the COVID-19 pandemic.
Among the initiatives proposed is a new EU database to monitor and report medicine shortages. MEPs have called for a new Medicines Supply Database to avoid medicines shortages and to increase transparency and the availability of public information about clinical trials. The new database would facilitate, on a permanent basis, access and exchange of information between the Agency and corresponding national authorities.
The EU Parliament also wants to promote clinical trials for the development of vaccines and treatments. The experience of running clinical trials during the pandemic revealed a number of shortcomings, including duplication of efforts, the under-representation of important population subgroups in trials, based on gender, age, ethnicity or medical comorbidities, and a lack of collaboration between trials. To improve on this, the Parliament has called for more coordinated, well-designed and transparent clinical trials. In addition, the Parliament wants information on clinical trials and marketing authorisation decisions to be publicised.
The European Parliament’s Committee on the Environment, Public Health and Food Safety (ENVI) is the responsible committee and Ireland South MEP Deirdre Clune is a substitute member of this committee.
Ireland South MEP Deirdre Clune said a stronger European Medicines Agency “will help the EU to prevent shortages of medicines and medical devices and will also be faster in developing medicines to fight any disease which could cause a crisis in the future.”
“We have seen from the pandemic that agencies such as the EMA did not have enough powers or sufficient resources when a criss did hit. I welcome the news that we are planning to strengthen the EMA’s capacity to deal with future emergencies. We need to ensure that Europe can work together in a coordinated way if we are faced with future health crises. A stronger European Medicines Agency will play a key role in this and it will help us to plan for the future when it comes to managing public health across the EU,” said MEP Clune.
Within this proposal, Parliament also agreed that newly established Agency bodies, such as the Medicines Steering Group and the Medical Devices Steering Group, should include permanent observers from bodies representing patients and medical professionals, as well as invite contributions from third parties including marketing authorisation holders, wholesale distributors, or other appropriate industry, patients’, consumers’ and healthcare professionals’ groups. Members of these bodies must not have interests in related industry sectors that could affect their impartiality. The EMA should make these member lists and proceedings publicly available.
The draft rules to strengthen the EMA’s mandate are part of a broader European Health Union package, also including a strengthened mandate for the European Centre for Disease Prevention and Control (ECDC).